Degenerative diseases of the spine
Conditions
Interventions
Freeze-dried tissue-engineered bone set:This is an autologous-controlled prospective clinical study in which subjects undergoing bi-segmental unilateral decompression-TLIF surgery underwent interbody
Sponsors
Southwest Hospital, The Army Medical University, Chongqing, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Suffering from lumbar degenerative diseases such as lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis (I.-II.°), and ineffective after at least 3 months of conservative treatment, and at the same time have surgical indications for lumbar bisegmental fusion; 2. Accept the random selection of different bone graft materials in different vertebral spaces, voluntarily take the test and sign the informed consent form; 3. Normal liver and kidney function, erythrocyte sedimentation rate and C-reactive protein; 4. Gender is not limited, older than 18 years old, less than or equal to 75 years old; 5. Good comprehension and compliance, able to communicate well with the investigator and comply with the requirements of the whole trial.
Exclusion criteria
Exclusion criteria: 1. Active infection in the whole body; 2. Obvious local inflammation; 3. Fever or abnormal blood count; 4. Suffering from mental illness; 5. Any potential conditions that may affect the effect of fusion device implantation, such as: malignant tumors, congenital malformations, history of previous related surgeries, history of drug abuse; 6. Diseases and hereditary diseases that seriously affect the bone shaping process, such as Paget's bone disease, etc.; 7. Tumor patients; 8. Patients with severe osteoporosis (T less than or equal to -2.5 and history of fracture); 9. Those who are prone to allergies and rejection; 10. Patients who have no indication for fusion surgery or only need to undergo single-segment fusion; 11. Those who have poor compliance and cannot follow up on time; 12. Investigators who are participating in or have just finished other clinical trials; 13. Other circumstances that the investigator thinks are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical segmental fusion rate;Local skin healing at the graft site;erythrocyte sedimentation rate (ESR);Operative range of motion;Surgical segmental complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| hepatic function;renal function;c reactive protein; | — |
Countries
China
Contacts
Public ContactHou Tianyong
Chinese First Affiliated Hospital of the Army Medical University of the People's Liberation Army
Outcome results
None listed